Institutions are mandated by the IACUC and through the Institutional Official to report any sanctions or interruptions in protocol activity imposed by the IACUC due to noncompliance or serious deviations from the Guide for the Care and Use of Laboratory Animals1 to the Office of Laboratory Animal Welfare (OLAW) in accordance with federal guidelines such as the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals2 (Policy). Guidance to PHS awardee institutions and IACUCs on PHS Policy requirements for prompt reporting of noncompliance is provided in the National Institutes of Health Guide and Contracts notice number NOT-OD-05-034 (ref. 3). This guidance is intended to assist IACUCs and Institutional Officials in determining when and how noncompliance should be reported and to promote greater uniformity in reporting.
According to the PHS Policy2, conditions that jeopardize the health or well-being of animals, resulting in actual harm or death to animals, should be reported. In this scenario, Linda Girard reasoned that she was overwhelmed with lab work and admitted taking shortcuts in aseptic and surgical technique, contrary to her IACUC training, which led to wound dehiscence and infections. This is definitely an issue of noncompliance and a reportable incident to OLAW. Because of the noncompliance, the Principal Investigator (PI)'s protocol should be temporarily halted until Girard and all personnel listed on the IACUC-approved protocol are retrained in the survival surgical procedures described in this project. All the animals that underwent survival surgeries by Girard may need to be euthanized owing to the possibility of infections. The PI should be advised of his or her responsibility for all aspects of the approved project, including assurance that all research staff involved in handling animals in this project are qualified and appropriately trained in animal procedures, and should closely monitor personnel working with animals on this protocol to avoid the same mistake in the future. Girard and the PI should be clearly informed of the consequences of protocol noncompliance, irrespective of any reasons for the noncompliance, such as overwhelming workload. We agree that additional IACUC monitoring of Girard's work should be mandated, and we advise the IACUC to monitor procedures carried out by other personnel listed in the protocol as well.
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